Efficacy and Safety of High Dose Baclofen for Alcohol Dependence

NCT01980706 | Completed Phase 2 Results DMC

• 2 other identifiers: 12-17434R01AA020824-04
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will carefully test the hypothesis that a robust dose of baclofen (90 mg/day) has efficacy and is safe in individuals with alcohol dependence. Furthermore, the proposal will test whether an indicator of physical dependence, i.e. drinks/drinking day, predicts response to baclofen. Additionally, the proposal will examine the anti-anxiety effects of baclofen within an alcohol dependent population and ascertain whether baseline levels of anxiety predict response to baclofen.

Conditions

Alcoholism

Keywords

Baclofen; Alcohol Dependence

Outcome Measures

Primary Outcomes (2)

• Mean Percentage of Heavy Drinking Days

  The frequency of heavy drinking days (5 or more drinks for a man and 4 or more drinks for a woman) as percentage during the treatment phase.

  Every 1-2 weeks up to 16 weeks of active trial

• Mean Percentage of Abstinent Drinking Days

  Percent of abstinent days over the course of the trial.

  Every 1-2 weeks up to 16 weeks of active trial

Secondary Outcomes (3)

• Mean Spielberger State-Trait Anxiety Inventory Score [State]

  Every 1-2 weeks up to 16 weeks of active trial

• Mean Penn Alcohol Craving Scale Score

  Every 1-2 weeks up to 16 weeks of active trial

• Carbohydrate-deficient Transferrin

  End of trial, generally 16 weeks

Other Outcomes (1)

• Self-reported Sedation on at Least One Occasion by a Participant

  Every 1-2 weeks up to 16 weeks of active trial

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.

Drug: Placebo

30 Mg Baclofen

ACTIVE COMPARATOR

Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.

Drug: Baclofen

90 mg Baclofen

ACTIVE COMPARATOR

Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.

Drug: Baclofen

Interventions

Baclofen DRUG

Baclofen is a GABA-B agonist

Also known as: Lioresal

30 Mg Baclofen; 90 mg Baclofen

Placebo DRUG

Pill containing no pharmacologically active substance.

Also known as: Sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 65 meeting Diagnostic and Statistical Manual (DSM)-IV criteria for current alcohol dependence.
• More than 14 drinks (women) or 21 drinks (men) per week including at least 2 heavy drinking days (men \> 5 drinks/day; women \> 4 drinks/day) per week in the 30-day period prior to screening. In addition we will recruit 50% of individuals who have a mean of ≥14 drinks/drinking day (men) or ≥10 drinks/drinking day (women) in the 30 days prior to screening.
• Ability to understand and sign written informed consent.
• Must have a 0.0 gms/dL breathalyzer reading on the day of screening and 0.0 gms/dL on the day of randomization.
• Express a desire to achieve abstinence or to greatly reduce alcohol consumption
• Must have a stable residence and be able to identify an individual who could contact participant if needed.

You may not qualify if:

• Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., renal insufficiency, cirrhosis, unstable hypertension, diabetes mellitus, seizure disorder). Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, severe depression, or suicidal ideation.
• Other substance abuse or dependence disorder other than nicotine or alcohol or cannabis abuse.
• Occasional use of cocaine is acceptable.
• Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics with the exception of stable doses of antidepressants for one month. Concurrent use of anticonvulsants, insulin, or oral hypoglycemics.
• Prior history of adverse reaction to baclofen.
• Creatinine level \> Upper Limit of Normal (ULN) or Estimated Glomerular Filtration Rate \< age norm.
• aspartate aminotransferase (AST), or alanine transaminase (ALT) \> 5 times ULN or bilirubin \> 1.5 X ULN.
• Positive urine toxicology screen with the exception of cannabis. Individuals with positive cannabis screens will be excluded only if they have a history of cannabis dependence.
• Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).
• Women who are breastfeeding.
• Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence.
• Participation in any clinical trial within the past 60 days.
• Court-mandated participation in alcohol treatment or pending incarceration.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Baclofen; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: James C Garbutt, MD
• Organization: University of North Carolina at Chapel Hill

jc_garbutt@med.unc.edu

984-974-2201

Study Officials

• James C Garbutt, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 11, 2013
• Study Start: December 12, 2013
• Primary Completion: October 26, 2017
• Study Completion: October 26, 2017
• Last Updated: June 12, 2019
• Results First Posted: January 8, 2019

Record last verified: 2018-10

Locations

US (1)